Companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States are regulated by FDA's Center for Devices and Radiological Health (CDRH).
The owner of the device/product could have designed it but then had it manufactured by a contract manufacturer.
Do You Know…
What It Means When FDA "Clears" or "Approves" a Medical Device?
When FDA review is needed prior to marketing a medical device, FDA will either "clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or More...
FDA Basics Videos
Alberto Gutierrez, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health on new diagnostic tests and personalized medicine. Watch FDA Basics Videos...
Medical Device Basics
What is a medical device? Does FDA regulate medical devices? Do I need a prescription for a medical device? Who can write a prescription for a medical device? What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices? Are medical devices regulated for non-medical reasons?
Device Review Process
Information About Devices
How can I find out if a medical device is cleared or approved? Can you tell me when a medical device will be cleared or approved in the future? Can you tell me how the submission of a medical device application is going? How can I find out if my medical device has been recalled? Who can I contact if my question wasn’t answered or I have additional questions in the future?
How can I get information about the safety of a medical device after it has been cleared or approved? If I have a concern about a medical device, can I send it to FDA to be tested? What does ‘recall’ mean? What does a recall mean for an implanted device? What should I do if I am hurt by a medical device or if a medical device doesn’t work properly? I am a patient and would like to participate in a clinical study for a new device or procedure. How can I find out more about the study?
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